Japanese Pharma Must Face Antitrust Action

(CN) – Japanese drugmaker Astellas Pharma must face claims that it tried to ban generic versions of its transplant drug Prograf to extend its monopoly, rather than out of genuine concern for public wellbeing, a federal judge in Boston found.

A group of consumers who bought Prograf, Astellas’ brand-name version of the immunosuppressant drug tacrolimus, claims the company filed a “sham” petition to the Food and Drug Administration to try to halt the approval of a generic version – and raked in almost $1 billion in artificially inflated prices while the FDA considered its petition. Eight “substantively identical” antitrust cases filed against Astellas around the country were consolidated and transferred to federal court in Massachusetts. The consolidated complaint alleged that in September 2007, Astellas “filed a baseless citizen petition with the FDA with the sole intent of foreclosing market entry by generic competitors, that improperly extended its monopoly and kept Prograf prices at supra-competitive levels,” according to the ruling. While the FDA provides a 180-day period for resolving citizen petitions, the class claimed that the FDA frequently takes much longer to respond. In this case, the FDA took nearly two years to respond to Astellas’ citizen petition. In an August 2009 letter, the FDA “described numerous deficiencies in Astellas’ submission and denied nearly all of the relief requests,” the ruling states. That same day, the FDA approved an application filed by drug maker Sandoz to sell a generic brand of the drug. One day later, Astellas sued the FDA in federal court in the District of Columbia, asserting that its decision was arbitrary and capricious, but Astellas’ motion for a temporary restraining order was denied. In April 2010, the consumers filed class action lawsuits claiming that “U.S. Prograf sales were worth $929 million for the 12 months ending in April 2009, and the citizen petition was filed only for the purpose of extending Astellas’ position as the sole tacrolimus provider, not for any legitimate concern about the efficacy or safety of generic tacrolimus,” according to the ruling. Astrellas moved to dismiss, claiming that its citizen petition was protected by the First Amendment. U.S. District Judge Rya Zobel disagreed. “When petitioning conduct is a mere sham to cover what is actually nothing more than an attempt to interfere directly with the business relationship of a competitor, such conduct is not immune.” Zobel found that the allegations were “more than sufficient to withstand a motion to dismiss.” She specifically cited plaintiffs’ allegations that Astellas “advocated for relief in its citizen petition that it knew would not be granted by the FDA, and that had been previously and repeatedly rejected by the FDA, and Prograf sales were $929 million for 2009, giving Astellas an incredibly strong financial incentive to extend its position as the sole tacrolimus provider.” Astellas faces a class action antitrust claim from insurance companies based on similar allegations.